Small Bowel/Small Bowel-Liver/Multivisceral Transplantation
DESCRIPTION
Small bowel transplant is the transplantation of an intestinal allograft to an individual with irreversible intestinal failure to restore intestinal function. Intestinal failure is the inability of the small bowel to absorb adequate nutrition and fluids due to loss in length, function, and/or absorptive capacity of the small bowel, resulting in malabsorption, malnutrition, and dehydration. The most common cause of intestinal failure is short bowel syndrome (SBS) or short gut syndrome, a congenital disorder in which an infant's intestine is too short or underdeveloped to allow normal food digestion. Other causes may include abdominal trauma, Crohn's disease, thrombotic disorders and surgical adhesions.
Total parenteral nutrition (TPN) can produce long-term survival once small intestinal dysfunction makes oral nutrition ineffective. Complications resulting from TPN use may lead to serious morbidity and mortality. Small bowel transplantation can be performed in one of three ways: alone, in combination with the liver, or multi-visceral (i.e., with one or more of the following: liver, pancreas, stomach, duodenum, intestine and colon).
POLICY
Small bowel transplantation for the treatment of irreversible intestinal failure is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Small bowel - liver transplantation for the treatment of irreversible intestinal failure is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Multivisceral transplantation for the treatment of irreversible intestinal failure is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Multiple labs and work-up procedures are considered not medically necessary for the sole purpose of repeat evaluation at multiple transplant centers.
Repeated labs and procedures are considered medically necessary to address changes in condition and for continued transplant listing.
See also:
MEDICAL APPROPRIATENESS
Small bowel transplantation (cadaveric or living donor) for the treatment of irreversible intestinal failure is considered medically appropriate with ALL of the following:
Clinical information submitted for determination of medical appropriateness criteria is dated within the last 7 months
Total parenteral nutrition (TPN) has failed
ABSENCE of alcohol or drug use with ANY ONE of the following:
No history of alcohol or drug use
In individuals with a history of alcohol or drug use, ALL of the following:
Documented six month abstinence from drug or alcohol use
Ongoing participation in a formal treatment program
ANY ONE of the following:
Short gut syndrome with loss of over 70% of the native small bowel
Defective intestinal motility (e.g., hollow visceral myopathy, neuropathy, and / or total intestinal aganglionosis)
Impaired enterocyte absorptive capacity (e.g., microvillus inclusion disease, selective autoimmune enteropathy, radiation enteritis, extensive inflammatory bowel disease and / or massive intestinal polyposis)
Failure of transplanted graft of small bowel
ABSENCE of absolute contraindications, including ALL of the following:
Life expectancy of less than five years due to age-related debilitation and co-morbidities
Ability to ingest oral nutrition
Unresectable malignancy
Serious, uncontrolled psychiatric illness that would hinder compliance with any stage of the transplant process
Neurologic illness independent of the disease process being treated
Active substance abuse (alcohol, drugs, or other toxins)
Active and / or life-threatening infection
Severe body / organ system disease unrelated to transplanted organ
Compromised cardio-pulmonary function unrelated to transplanted organ
Inability or unwillingness of the individual or legal guardian to give signed consent and to comply with regular follow-up requirements
Small bowel - liver transplantation for the treatment of irreversible intestinal failure is considered medically appropriate with ALL the following:
Clinical information submitted for determination of medical appropriateness criteria is dated within the last 7 months
Total parenteral nutrition (TPN) has failed
ANY of the following:
Irreversible failure of both liver and intestines
Liver failure associated with total thrombosis of the portomesenteric system
ABSENCE of alcohol or drug use with ANY ONE of the following:
No history of alcohol or drug use
In individuals with a history of alcohol or drug use, ALL of the following:
Documented six month abstinence from drug or alcohol use
Ongoing participation in a formal treatment program
ABSENCE of absolute contraindications, including ALL of the following:
Extrahepatic malignancy including cholangiocarcinoma with the past five years with the exception of basal cell and squamous cell carcinoma of skin
Hepatocellular carcinoma that has extended beyond the liver
Uncontrolled systemic sepsis
Active substance abuse (e.g., alcohol, drugs)
Irreversible advanced cardiac, pulmonary, renal, neurologic or other organ disease
Evidence of significant non-compliance
Active substance abuse (alcohol, drugs, or other toxins)
History of alcohol or drug use, must meet ALL of the following:
Documented six month abstinence from drug or alcohol use
Ongoing participation in a formal treatment program
Medical therapy has been optimal and no surgical procedure other than transplantation offers a realistic expectation of functional improvement and extension of life, in the presence of end-stage liver failure due to an irreversibly damaged liver
ANY ONE of the following:
Hepatocellular with ANY of the following:
Cryptogenic cirrhosis
Chronic viral hepatitis
Autoimmune hepatitis
Alpha-1 antitrypsin deficiency
Protoporphyria.
Alcoholic cirrhosis including ALL of the following:
Confirmation of the abstinence of alcoholic for six months
Ongoing participation in a formal treatment program
Fulminant hepatic failure with ANY of the following:
Viral hepatitis (if the etiology is thought to be related to IV drug use) with ALL the following:
Confirmation of the abstinence from IV drugs for six months
Ongoing participation in a formal treatment program
Drugs or toxins with ALL the following:
Confirmation of the abstinence from IV drugs for six months
Ongoing participation in a formal treatment program
Wilson’s disease
Cholestatic liver diseases with ANY the following:
Biliary cirrhosis (primary or secondary)
Sclerosing cholangitis
Biliary atresia
Vascular disease (e.g., Budd-Chiari syndrome)
Primary hepatocellular carcinoma
Metabolic disorders with ANY of the following:
Hemochromatosis
Glycogen storage disease
Familial hypercholesterolemia
Trauma and toxic reactions
Polycystic disease of the liver; with ANY of the following:
Enlargement of liver impinging on respiratory function
Extremely painful enlargement of liver
Enlargement of liver significantly compressing and interfering with function of other abdominal organs
Familial amyloid polyneuropathy when the individual is a liver transplant candidate based on the morbidity of the polyneuropathy
Multivisceral transplantation for the treatment of irreversible intestinal failure is considered medically appropriate with ALL the following:
Clinical information submitted for determination of medical appropriateness criteria is dated within the last 7 months
Total parenteral nutrition (TPN) has failed
ANY of the following:
Combined organ failure and / or premalignant conditions of the gastrointestinal tract, which includes three or more of the abdominal visceral organs including the small bowel
Extensive thrombosis of the splanchnic vascular system, massive gastrointestinal polyposis, and generalized hollow visceral myopathy or neuropathy
ABSENCE of alcohol or drug use with ANY ONE of the following:
No history of alcohol or drug use
In individuals with a history of alcohol or drug use, ALL of the following:
Documented six month abstinence from drug or alcohol use
Ongoing participation in a formal treatment program
ABSENCE of absolute contraindications, including ALL of the following:
Extrahepatic malignancy including cholangiocarcinoma with the past five years with the exception of basal cell and squamous cell carcinoma of skin
Hepatocellular carcinoma that has extended beyond the liver
Uncontrolled systemic sepsis
Active substance abuse (e.g., alcohol, drugs)
Irreversible advanced cardiac, pulmonary, renal, neurologic or other organ disease
Evidence of significant non-compliance
Active substance abuse (alcohol, drugs, or other toxins)
History of alcohol or drug use, must meet ALL of the following:
Documented six month abstinence from drug or alcohol use
Ongoing participation in a formal treatment program
Medical therapy has been optimal and no surgical procedure other than transplantation offers a realistic expectation of functional improvement and extension of life, in the presence of end-stage liver failure due to an irreversibly damaged liver
ANY ONE of the following:
Hepatocellular with ANY of the following:
Cryptogenic cirrhosis
Chronic viral hepatitis
Autoimmune hepatitis
Alpha-1 antitrypsin deficiency
Protoporphyria
Alcoholic cirrhosis including ALL of the following:
Confirmation of the abstinence of alcoholic for six months
Ongoing participation in a formal treatment program
Fulminant hepatic failure with ANY of the following:
Viral hepatitis (if the etiology is thought to be related to IV drug use) with ALL the following:
Confirmation of the abstinence from IV drugs for six months
Ongoing participation in a formal treatment program
Drugs or toxins with ALL the following:
Confirmation of the abstinence from IV drugs for six months
Ongoing participation in a formal treatment program
Wilson’s disease
Cholestatic liver diseases with ANY the following:
Biliary cirrhosis (primary or secondary)
Sclerosing cholangitis
Biliary atresia
Vascular disease (e.g., Budd-Chiari syndrome)
Primary hepatocellular carcinoma
Metabolic disorders with ANY of the following:
Hemochromatosis
Glycogen storage disease
Familial hypercholesterolemia
Trauma and toxic reactions
Polycystic disease of the liver; with ANY of the following:
Enlargement of liver impinging on respiratory function
Extremely painful enlargement of liver
Enlargement of liver significantly compressing and interfering with function of other abdominal organs
Familial amyloid polyneuropathy when the individual is a liver transplant candidate based on the morbidity of the polyneuropathy
ADDITIONAL INFORMATION
Indications of failed TPN include any of the following:
Impending liver failure due to TPN-induced liver injury
Limited central venous access
Frequent central line infection and sepsis
Frequent episodes of severe dehydration despite intravenous fluid supplementation with TP
Small bowel transplants should be performed in a facility that is licensed, accredited, and approved by Medicare as an Intestinal Transplant Center. The Medicare list is available at http://www.cms.hhs.gov/providers/transplant/.
The center responsible for the organ harvesting should comply with the United Network of Organ Sharing (UNOS) guidelines: Minimum Procurement Standards For An Organ Procurement Organization (OPO) located at http://www.unos.org/policiesandbylaws/policies.asp?resources=true.
SOURCES
Abu-Elmagd, K., & Bond, G. (2003). Gut failure and abdominal visceral transplantation. Proceedings of the Nutrition Society, 62, 727-737.
American Association for the Study of Liver Diseases. (2005). AASLD practice guidelines: Evaluation of the patient for liver transplantation. Retrieved June 27, 2005 from https://www.aasld.org/eweb/docs/practiceguidelines/evalu_patient_livertransplantation.pdf.
American Gastroenterological Association. (2003). American Gastroenterological Association Medical Position Statement: Short bowel syndrome and intestinal transplantation. Gastroenterology, 124 (4), 1105-1110.
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2006). Small bowel / liver and multivisceral transplant (7.03.05). Retrieved February 8, 2006 from BlueWeb.
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2006). Small bowel transplant (7.03.04). Retrieved February 8, 2006 from BlueWeb.
Complete Guide to Medicare Coverage Issues [Computer software]. (2006, November). Adult liver transplantation. (NCD 260.1, p. 2-193) St. Anthony Publishing.
Complete Guide to Medicare Coverage Issues [Computer software]. (2006, November). Intestinal and multi-visceral transplantation (NCD 260.5, p. 2-196). St. Anthony Publishing.
Complete Guide to Medicare Coverage Issues [Computer software]. (2006, November). Pediatric liver transplantation. (NCD 260.2, p. 2-194) St. Anthony Publishing.
Complete Guide to Medicare Coverage Issues. (2007, January). Medicare approved adult and pediatric intestinal transplant centers. Retrieved February 8, 2007 from http://www.cms.hhs.gov/ApprovedTransplantCenters/downloads/intestinal_list.pdf.
Florman, S., Kaufman, S. S., & Fishbein, T. (2005) Decision making in intestinal transplantation. Progress in transplantation, 15 (1); 65-68. Retrieved June 7, 2005 from http://www.findarticles.com/p/articles/mi_qa4117/is_200503/ai_n13476266.
Fryer, J. P. (2005) Intestinal transplantation: An update. Current opinion in gastroenterology, 21 (2); 162-168.
Grant, D., Abu-Elmagd, K., Reyes, J., Tzakis, A., Langnas, A., Fishbein, T., et al; on behalf of the Intestine Transplant Registry. (2005). 2003 report of the intestine transplant registry: A new era has dawned. Annals of surgery, 241 (4); 607-613.
Health Technology Assessment Information Service. Windows on Medical Technology. (2000, April). Intestine and intestine-liver transplantation: Update. Retrieved June 3, 2003 from ECRI HTAIS.
Robinson, J. I., & Spencer, R. W. (2005) Intestinal transplantation: the evaluation process. Progress in transplantation, 15 (1); 45-53. Retrieved June 7, 2005 from http://www.findarticles.com/p/articles/mi_qa4117/is_200503/ai_n13476223.
Sudan, D. L., Kaufman, S. S., Shaw, B. W. Jr., Fox, I. J., McCashland, T. M., Schafer, D. F., et al. (2000). Isolated intestinal transplantation for intestinal failure. American Journal Gastroenterology, 95 (6), 1506-1515. Abstract retrieved July 17, 2001 from PubMed database.
The Organ Procurement and Transplant Network. (2005). Organ datasource, intestine. Retrieved May 26, 2005 from http://www.optn.org/organDatasource/about.asp?display=Intestine.
The Technology Evaluation Center. (1996, March). Transplants involving the small bowel (Vol. 10, No. 27). Chicago: BlueCross BlueShield Association.
The Technology Evaluation Center. (1999, July). Small bowel transplants in adults and multivisceral transplants in adults and children (Vol. 14, No. 9). Chicago: BlueCross BlueShield Association.
University of Michigan. Department of Surgery. Section of Pediatric Surgery. (2004). Short bowel syndrome (SBS) in children. Retrieved June 7, 2005 from http://www.pediatric.um-surgery.org/program/sbs/B_short.html.
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EFFECTIVE DATE |
5/1/2008 |
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